MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CRTS SM IL SG VLV UTZ CATH ACC; CERTAS PLUS SMALL & RA W/SG

Catalog Number 828816

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Swelling (2091)

Event Date 10/30/2020

Event Type  Injury  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A physician reported that the certas valve was implanted to a (b)(6)-old girl via v-p shunt on (b)(6) 2020 with unknown settings.After placing the valve, the hydrocephalus symptoms recovered.In the middle of (b)(6), csf retention under the skin around the valve and swelling were observed.Although the patient's condition was stable, on (b)(6) 2020, the valve (with a setting of 5) was replaced with a new one.No further information was provided by hospital.

Manufacturer Narrative

Unique device identifier (udi) : (b)(4).The valve was returned for evaluation: failure analysis - the valve was visually inspected, needle holes in the needle chamber were noted.The valve was leak tested, only leaked from the needle holes in the needle chamber.The valve passed the test for programming, flushed, occlusion, reflux, siphon guard and pressure.No root cause could be determined as the technician could not confirm any problem with the valve at the time of investigation.The possible root cause for "csf retention under skin around the valve and swelling were observed" could be due to surgical technique / user handling (as specified in ifu - surgical procedure precautions - verify proper placement and integrity of ligatures at all tubing junctions to prevent tears or abrasion of the silicone tubing).At the time of investigation no issues were noted with the valve.

• Brand Name: CRTS SM IL SG VLV UTZ CATH ACC
• Type of Device: CERTAS PLUS SMALL & RA W/SG
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• MDR Report Key: 10877502
• MDR Text Key: 217458649
• Report Number: 3013886523-2020-00210
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 828816
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2020
• Date Manufacturer Received: 12/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 2 MO